<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00020221262087</udiDi>
    <basicUdiDi>B-00020221262087</basicUdiDi>
    <tradeName>EXEL 2-3mL AMBER SYR ONLY L-S W/ TIP CAP</tradeName>
    <deviceName>Syringe only</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>W01029004</emdnCode>
    <emdnDescription>COATED TUBES AND BEADS (UNASSIGNABLE) (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26208</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:23.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260854</udiDi>
    <basicUdiDi>B-00020221260854</basicUdiDi>
    <tradeName>EXEL DEHP-FREE PRIMARY SOLUTION SET</tradeName>
    <deviceName>IV Administration Set</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26085</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:22.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260670</udiDi>
    <basicUdiDi>B-00020221260670</basicUdiDi>
    <tradeName>EXEL 1mL TB 23G x 1"-0-DEAD-SPACE</tradeName>
    <deviceName>Tuberculin Syringe</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A020109</emdnCode>
    <emdnDescription>TUBERCULIN SYRINGES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26067</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:21.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260663</udiDi>
    <basicUdiDi>B-00020221260663</basicUdiDi>
    <tradeName>EXEL 1mL TB 25G x 1"-0-DEAD-SPACE</tradeName>
    <deviceName>Tuberculin Syringe</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A020109</emdnCode>
    <emdnDescription>TUBERCULIN SYRINGES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26066</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:17.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260632</udiDi>
    <basicUdiDi>B-00020221260632</basicUdiDi>
    <tradeName>EXEL 1mL ALLERGY SYR 27GX3/8", INTRADERMAL  BEVEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26063</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:17.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260625</udiDi>
    <basicUdiDi>B-00020221260625</basicUdiDi>
    <tradeName>EXEL 1mL ALLERGY SYR 27GX1/2"</tradeName>
    <deviceName>Allergy Syringe</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26062</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:16.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260618</udiDi>
    <basicUdiDi>B-00020221260618</basicUdiDi>
    <tradeName>EXEL 1mL ALLERGY SYR 27GX1/2"</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26061</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:15.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260564</udiDi>
    <basicUdiDi>B-00020221260564</basicUdiDi>
    <tradeName>EXEL 1ml Syringe 25G x 1" LDS</tradeName>
    <deviceName>Tuberculin Syringe</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A020109</emdnCode>
    <emdnDescription>TUBERCULIN SYRINGES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26056</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:11.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260595</udiDi>
    <basicUdiDi>B-00020221260595</basicUdiDi>
    <tradeName>EXEL 1mL LDS SYR 20G x 1"</tradeName>
    <deviceName>Syringe with needle</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26059</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:10.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260571</udiDi>
    <basicUdiDi>B-00020221260571</basicUdiDi>
    <tradeName>EXEL 1ml Syringe 23G x 1" LDS</tradeName>
    <deviceName>Tuberculin Syringe</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A020109</emdnCode>
    <emdnDescription>TUBERCULIN SYRINGES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26057</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:09.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260519</udiDi>
    <basicUdiDi>B-00020221260519</basicUdiDi>
    <tradeName>EXEL 1mL TB 21Gx1"-0-DEAD-SPACE</tradeName>
    <deviceName>Tuberculin Syringe</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A020109</emdnCode>
    <emdnDescription>TUBERCULIN SYRINGES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26051</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:09.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260465</udiDi>
    <basicUdiDi>B-00020221260465</basicUdiDi>
    <tradeName>EXEL 1mL TB 25G X 5/8"-0-DEAD-SPACE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020109</emdnCode>
    <emdnDescription>TUBERCULIN SYRINGES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26046</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:52.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260410</udiDi>
    <basicUdiDi>B-00020221260410</basicUdiDi>
    <tradeName>EXEL 1ml TB 30G x 1/2"</tradeName>
    <deviceName>Tuberculin Syringe</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A020109</emdnCode>
    <emdnDescription>TUBERCULIN SYRINGES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26041</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:52.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260397</udiDi>
    <basicUdiDi>B-00020221260397</basicUdiDi>
    <tradeName>EXEL 1mL AMBER SYR ONLY LUER LOCK W/ TIP CAP</tradeName>
    <deviceName>Syringe only</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>W01029004</emdnCode>
    <emdnDescription>COATED TUBES AND BEADS (UNASSIGNABLE) (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26039</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:50.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260380</udiDi>
    <basicUdiDi>B-00020221260380</basicUdiDi>
    <tradeName>EXEL 1mL AMBER SYR ONLY LUER SLIP W/ TIP CAP</tradeName>
    <deviceName>Syringe only</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>W01029004</emdnCode>
    <emdnDescription>COATED TUBES AND BEADS (UNASSIGNABLE) (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26038</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:48.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260373</udiDi>
    <basicUdiDi>B-00020221260373</basicUdiDi>
    <tradeName>EXEL U-40 1mL INS SYR 29GX1/2"</tradeName>
    <deviceName>Insulin Syringe</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010601</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26037</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:46.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260366</udiDi>
    <basicUdiDi>B-00020221260366</basicUdiDi>
    <tradeName>EXEL U-40 1/2mL INS SYR 29GX1/2"</tradeName>
    <deviceName>Insulin Syringe</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010601</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26036</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:45.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260342</udiDi>
    <basicUdiDi>B-00020221260342</basicUdiDi>
    <tradeName>EXEL 1mL INS 28GX1/2"</tradeName>
    <deviceName>Insulin Syringe</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010601</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26034</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:44.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260328</udiDi>
    <basicUdiDi>B-00020221260328</basicUdiDi>
    <tradeName>EXEL 1/2mL INS 28GX1/2"</tradeName>
    <deviceName>Insulin Syringe</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010601</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26032</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:41.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260243</udiDi>
    <basicUdiDi>B-00020221260243</basicUdiDi>
    <tradeName>EXEL 1/2mL INS SYR 28GX1/2"</tradeName>
    <deviceName>Insulin Syringe</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010601</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26024</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:40.529Z</lastUpdated>
  </row>
</eudamedExport>